In this conversation with chronic pain specialist James Dillard, MD, I explore whether natural pain relief methods are well-researched, and I ask about what goes into scientific research anyhow.
Loolwa Khazzoom: It seems to me that the medical establishment pushes pharmaceutical responses to pain, instead of exploring and recommending natural pain relief methods.
James Dillard MD: I think that’s absolutely true. In my experience, the vast majority of pain specialists and the vast majority of non-pain specialist physicians don’t recommend complementary and alternative remedies as a matter of routine. If you have M.D. after your name, you’re focused on the drugs and injections and, to some degree, physical therapy.
LK: Is there not enough scientific research about natural pain relief methods?
JD: There are a plethora of single scientific studies on a wide variety of natural healing remedies. It is not correct, it is patently incorrect, that there is not good research in this area. There actually is. Not only is there good research, but there are good meta-analytic studies and good systematic reviews. There are literally thousands and thousands of clinical trials in acupuncture, mind-body medicine, nutritional interventions, and manual therapies.
LK: Please explain the different kinds of studies and reviews.
JD: OK, we’ll go from the micro to the macro: On the micro level, you have an individual trial. For example, I designed a well-controlled trial of acupuncture for chronic migraine. I had inclusion and exclusion criteria; I gathered patients who wanted to be part of the study; I developed a sham; I did the treatment; and so on. I got all this data that I could statistically analyze. That’s an individual trial.
The next level up is a meta-analysis, in which researchers collect data from numerous individual trials with identical or similar principles. The researchers then meta-analyze the data: They take the raw results of, say, five or six different papers on acupuncture for chronic migraine, and put all that data together — utilizing standard systems and statistical methods. Then instead of having 120 patients in the single trial, they’ve got 700 patients in five different trials.
As researchers do the meta-analysis of that combined outcome, versus the outcome of a reasonable sham (also known as a control), the big question is, “Does this intervention work better than the sham intervention?” A meta-analysis gives more statistical power. It’s still a research study, although usually in the meta-analysis, there’s no actual experimentation. It is simply a re-analysis of multiple papers.
The next level up is a systematic review, in which a number of acknowledged experts — usually academically-based in the particular field — will get together and look at primary research papers and meta-analyses of research papers on a particular topic. They’ll read through all the papers and evaluate the quality of the different research trials — using statistical instruments to measure whether the quality of a paper is good, moderate, or poor. The most common of these instruments is called the Hadad Score.
Then a group of researchers will get together and review all these different papers of high, moderate, and poor quality. Following this review, they will come to a consensus statement, which they will publish in what’s known as a systematic review. A systematic review, again, is not primary research. It is an expert review of multiple papers, utilizing quality measures to evaluate the overall data, and asking the question, “Does this intervention help people significantly more than well-controlled shams?”
The systematic review is what we often look to for guidance in a medical setting. Single trials are usually not enough to tell us that much, unless they are huge longitudinal trials — like the Helsinki Heart Trial or the Harvard Nurse’s Study, which had 400,000 people studied over seven years. Those trials tend to give really good data, but most research in this area is not like that.
LK: Why would you say that’s the case?
JD: Because most regular research trials have 40, 60, or 120 participants. Phase I FDA trials for drugs have 500 or more participants; Phase II trials have more than 1,000; Phase III have 2,500-3,000. I probably don’t have the numbers exactly right, but those are more or less the criteria established by the FDA, to decide whether or not a drug is going to be released to the market. I’m using that as an example of what is considered to be a small trial versus a large trial.
If you study something like the Helsinki Heart Trial — where you have multiple interventions and multiple arms, using 400,000 people over seven years — you have a single experimental trial with a gigantic number of people and a very long follow-up. You can hang your hat on that. It’s not like they studied sixty people for three weeks.
LK: I want to make sure that I’m understanding you correctly. Are you saying that for complementary and alternative medical approaches, the research doesn’t get to this level — meaning we don’t necessarily have the same ability to say, “Yes, it’s 100%. This is going to work for 70% of the people”?
JD: It depends on what you’re talking about. The Helsinki Heart Trial looked at Vitamin C, Vitamin E, and Beta Carotene. It showed that Vitamin C and Vitamin E have virtually no statistical effect on whether or not people get heart disease. Furthermore, it showed that taking isolated Beta Carotene alone slightly increased rates of heart disease and cancer. Now, is Beta Carotene conventional? Well, no, probably not. It’s a nutritional intervention. My point is that you can’t just use sweeping generalities.
LK: It’s really like a case-by-case basis.
JD: Yes. You’ve got to be familiar with the research. You’ve got to talk to the people who know what they’re talking about. That’s why doctors go to meetings and listen to people whose work is in this area.
James N. Dillard, M.D., D.C., C.Ac., is one of the leading pain specialists in America and the author of numerous books on chronic pain, including The Chronic Pain Solution. His many media appearances have included The Oprah Winfrey Show, Good Morning America, and the CBS Evening News. He served as an assistant clinical professor at Columbia University College of Physicians and Surgeons for 12 years and also was the Medical Director of Columbia’s Rosenthal Center for Complementary and Alternative Medicine. He resigned from employment at Columbia in 2006, to go exclusively into private practice in Manhattan and in Stamford, CT. He also writes a medical column for the East Hampton Star.